GUEST COLUMNISTS

• Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?

  This article will share some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings — the inaugural UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Summit and the Clinical Trials Transformation Initiative (CTTI) Virtual Meetings for Stakeholder Engagement on ICH E6.

• System Risk Structures: A New Framework For Avoiding Disaster

  Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.

• How To Drive Powerful CAPAs With Lean Six Sigma

  Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.

• Nitrosamine Impurities In Medicines: What Have We Learned?

  This article discusses the new EMA report "Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines," sharing recommendations and the path forward suggested by the European regulators, as well as lessons learned from the GMP sampling, testing, and inspection processes.

• How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19

  For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.

• Culture Media Market Growth Drives Demand For New & Better Technologies

  With a rise in bioprocessing demand, the market for cell culture media—an essential component of bioprocessing—has also seen a surge in the last few years. This column takes a deep look at the market as measured in BioPlan’s 2020 17th Annual Report and Survey of Biopharmaceutical Manufacturing,

• Is The U.S. Ready For A Re-shored Pharma Supply Chain?

  In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

• ASTM E3219 Standards For Derivation Of Health Based Exposure Limits

  The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.